Back to resultsEffect of Timing of Tumor-Treating Fields Plus Short-Course Radiation (GERAS)
Primary Purpose
Newly Diagnosed Glioblastoma in Patients ≥70 Years
Status
Suspended
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
TTFields
Sponsored by
About this trial
This is an interventional treatment trial for Newly Diagnosed Glioblastoma in Patients ≥70 Years
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed, newly diagnosed glioblastoma (astrocytoma WHO grade IV)
- Indication for hypofractionated radiotherapy or hypofractionated chemo-radiotherapy with temozolomide
- Open biopsy or resection
- Craniotomy or intracranial biopsy site must be adequately healed
- Informed consent
- Age: >65 years
- KPS ≥50%
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent of participation
Exclusion Criteria:
- Concurrent participation in another competing interventional clinical trial studying a drug or treatment regimen.
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry
- Prior RT of the brain
- Patients who have not yet recovered from acute high-grade toxicities of prior therapies
- MRI or TTFields contraindication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants, patients with severe skull defects such as a missing bone flap, programmable shunts)
- Known hypersensitivity to conductive hydrogels
- Pregnant and lactating women
Sites / Locations
- University Hospital of Heidelberg, Radiation Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early Tumor Treating Fields (TTFields, Optune®) treatment
Late TTF treatment
Arm Description
TTF will be started together with hypofractionated radiotherapy (+/- 5 days) with or without Temozolomide (according to the standard and local physician's decision). Chemoradiotherapy with temozolomide and hypofractionated radiotherapy is regarded as standard therapy and not part of the intervention. In case of chemoradiotherapy temozolomide will be applied according to the standard of the participating trial center. Use of antiemetic and infection prophylaxis will be at the discretion of the investigator.
Patients will be treated with hypofractionated radiotherapy with or without temozolomide (according to the local standard and physician's decision). Radiotherapy and treatment with temozolomide is regarded as standard therapy and not part of the intervention. In case of chemoradiotherapy temozolomide will be applied according to the standard of the participating trial center. Use of antiemetic and infection prophylaxis will be at the discretion of the investigator. Late TTFields treatment will start 4 weeks after the end of radiotherapy.
Outcomes
Primary Outcome Measures
Safely conducted therapy rate (SCTR)
The proportion of patients fulfilling the inclusion/exclusion criteria who were treated for at least one week according to protocol and neither experienced neither NCI-CTC-AEs of Grade 3 nor 4
Number of participants with treatment related adverse events as assessed by CTCAE V 5.0.
Safety and tolerability of TTFields Treatment combined with radiotherapy/chemo-radiotherapy
Secondary Outcome Measures
Progression-free survival
according to RANO criteria
The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy.
Score on the EORTC QoL C15-Pal
The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy.
Score on the EORTC QoL BN20
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04218019
Brief Title
Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation
Acronym
GERAS
Official Title
Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation in Elderly Patients With Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Organizational reasons
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juergen Debus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess timing of TTFields use as well as safety, feasibility and preliminary efficacy of treatment with TTFields in elderly patients with newly diagnosed GBM simultaneous to RT/ CRT.
The primary aim of the trial is to establish a safely conducted therapy rate higher than 0.8 in the treatment arm.
Detailed Description
Despite the immense effort made over the years with different treatment modalities, the survival of patients with newly diagnosed GBM is still very poor; no treatment is curative; and the quality of life of patients with this tumor is compromised significantly, not only by their disease but also by side effects of these rigorous treatment plans. Especially in elderly patients, a treatment modality is needed that will improve the results of current standard treatments without further impairing the quality of life of these patients for their limited life span.
The objective is to test the feasibility and timing of treatment with the TTFields device in elderly patients with newly diagnosed GBM simultaneous or subsequent to RT/ CRT.
The primary rationale to conduct this study is to improve treatment in the segment of high-grade brain tumors with the highest medical need.
All procedures regarding TTFields are representing routine clinical care within the approved use of the medical product in Germany; the present trial aims to investigate the optimal timing of TTFields use in elderly GBM patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed Glioblastoma in Patients ≥70 Years
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Tumor Treating Fields (TTFields, Optune®) treatment
Arm Type
Experimental
Arm Description
TTF will be started together with hypofractionated radiotherapy (+/- 5 days) with or without Temozolomide (according to the standard and local physician's decision). Chemoradiotherapy with temozolomide and hypofractionated radiotherapy is regarded as standard therapy and not part of the intervention. In case of chemoradiotherapy temozolomide will be applied according to the standard of the participating trial center. Use of antiemetic and infection prophylaxis will be at the discretion of the investigator.
Arm Title
Late TTF treatment
Arm Type
Active Comparator
Arm Description
Patients will be treated with hypofractionated radiotherapy with or without temozolomide (according to the local standard and physician's decision). Radiotherapy and treatment with temozolomide is regarded as standard therapy and not part of the intervention. In case of chemoradiotherapy temozolomide will be applied according to the standard of the participating trial center. Use of antiemetic and infection prophylaxis will be at the discretion of the investigator. Late TTFields treatment will start 4 weeks after the end of radiotherapy.
Intervention Type
Device
Intervention Name(s)
TTFields
Intervention Description
The NovoTTF-200 A device used in this trial delivers very low intensity, alternating electric fields to the tumor site through the scalp. These fields are known as Tumor Treating Fields or TTFields.
Primary Outcome Measure Information:
Title
Safely conducted therapy rate (SCTR)
Description
The proportion of patients fulfilling the inclusion/exclusion criteria who were treated for at least one week according to protocol and neither experienced neither NCI-CTC-AEs of Grade 3 nor 4
Time Frame
at least one week of treatment
Title
Number of participants with treatment related adverse events as assessed by CTCAE V 5.0.
Description
Safety and tolerability of TTFields Treatment combined with radiotherapy/chemo-radiotherapy
Time Frame
within 31 weeks after treatment
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
according to RANO criteria
Time Frame
within 6 month after treatment
Title
The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy.
Description
Score on the EORTC QoL C15-Pal
Time Frame
within 31 weeks after treatment
Title
The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy.
Description
Score on the EORTC QoL BN20
Time Frame
within 31 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed, newly diagnosed glioblastoma (astrocytoma WHO grade IV)
Indication for hypofractionated radiotherapy or hypofractionated chemo-radiotherapy with temozolomide
Open biopsy or resection
Craniotomy or intracranial biopsy site must be adequately healed
Informed consent
Age: >65 years
KPS ≥50%
Ability of subject to understand character and individual consequences of the clinical trial
Written informed consent of participation
Exclusion Criteria:
Concurrent participation in another competing interventional clinical trial studying a drug or treatment regimen.
Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry
Prior RT of the brain
Patients who have not yet recovered from acute high-grade toxicities of prior therapies
MRI or TTFields contraindication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants, patients with severe skull defects such as a missing bone flap, programmable shunts)
Known hypersensitivity to conductive hydrogels
Pregnant and lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Debus, Prof.
Organizational Affiliation
Head of Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Heidelberg, Radiation Oncology
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation
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